Randomized Phase II Study of Ixabepilone Alone and Ixabepilone Plus Cetuximab as First-Line Treatment for Female Subjects With Triple Negative Locally Advanced Non-resectable and/or Metastatic Breast Cancer

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-05-31

Brief Summary

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The purpose of this study was to estimate the response rate of ixabepilone monotherapy, and the combination of ixabepilone plus cetuximab as first-line treatment of female subjects with triple negative (estrogen receptor \[ER\], progesterone receptor \[PR\], Human Epidermal Growth Factor Receptor 2 \[HER2\] negative) locally advanced non-resectable and/or metastatic breast cancer

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Detailed Description

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Conditions

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Triple Negative Locally Advanced Non-resectable Breast Cancer Metastatic Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A (ixabepilone 40 mg^2)

ixabepilone 40 mg/m\^2 every 3 weeks

Group Type EXPERIMENTAL

ixabepilone

Intervention Type DRUG

injection, intravenous (IV), until unacceptable toxicity or progression or 15 months after the Last Subject First Visit (LSFV), whichever comes first.

Ixabepilone 40 mg/m\^2 was administered as a 3-hour IV continuous infusion on Day 1 in a 21-day cycle provided the participant met the re-treatment criteria.

Arm B (cetuximab 250 mg/m^2 + ixabepilone 40 mg/m^2)

cetuximab 400 mg/m\^2 loading dose then 250 mg/m\^2 weekly + ixabepilone 40 mg/m\^2 every 3 weeks

Group Type EXPERIMENTAL

ixabepilone + cetuximab

Intervention Type DRUG

Ixabepilone: injection, IV, until unacceptable toxicity or progression or 15 months after the LSFV, whichever comes first.

Ixabepilone 40 mg/m\^2 was administered as a 3-hour IV continuous infusion on Day 1 in a 21-day cycle provided the participant meets the re-treatment criteria.

Cetuximab: injection, IV, until unacceptable toxicity or progression or 15 months after the LSFV, whichever comes first.

Cetuximab 400 mg/m\^2 was administered as a 2-hour IV loading dose via in-line filtration with an infusion pump, gravity drip, or a syringe pump on Day 1 of first cycle then 250 mg/m\^2 1-hour IV once a week, i.e. on Days 1, 8, and 15 of each cycle provided the participant meets the re-treatment criteria.

Interventions

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ixabepilone

injection, intravenous (IV), until unacceptable toxicity or progression or 15 months after the Last Subject First Visit (LSFV), whichever comes first.

Ixabepilone 40 mg/m\^2 was administered as a 3-hour IV continuous infusion on Day 1 in a 21-day cycle provided the participant met the re-treatment criteria.

Intervention Type DRUG

ixabepilone + cetuximab

Ixabepilone: injection, IV, until unacceptable toxicity or progression or 15 months after the LSFV, whichever comes first.

Ixabepilone 40 mg/m\^2 was administered as a 3-hour IV continuous infusion on Day 1 in a 21-day cycle provided the participant meets the re-treatment criteria.

Cetuximab: injection, IV, until unacceptable toxicity or progression or 15 months after the LSFV, whichever comes first.

Cetuximab 400 mg/m\^2 was administered as a 2-hour IV loading dose via in-line filtration with an infusion pump, gravity drip, or a syringe pump on Day 1 of first cycle then 250 mg/m\^2 1-hour IV once a week, i.e. on Days 1, 8, and 15 of each cycle provided the participant meets the re-treatment criteria.

Intervention Type DRUG

Other Intervention Names

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IXEMPRA BMS-247550 IXEMPRA BMS-247550 ERBITUX BMS-564717

Eligibility Criteria

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Inclusion Criteria

* Female subjects with triple negative (ER, PR, and HER2 negative) locally advanced non-resectable and/or metastatic breast cancer
* Prior adjuvant or neoadjuvant anthracycline-based chemotherapy

Exclusion Criteria

* Tumors that are fluorescence in situ hybridization test (FISH) positive or immunohistochemistry (IHC) 3+
* Neuropathy \> Grade 1
* Prior systemic therapy for metastatic disease

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No